Benzinga | Oct 4, 2021 09:03AM EDT

Acurx Pharma Reports Ibezapolstat Microbiome Data From Phase 2a Trial: 'trial demonstrated 100% clinical cure and sustained clinical cure,' Showed 'Favorable microbiome changes included overgrowth'

- Patient fecal samples were evaluated for C. difficile culture and microbiome changes

- Ph2a trial demonstrated 100% clinical cure and sustained clinical cure

- Favorable microbiome changes included overgrowth of Actinobacteria and Firmicutes phylum species while on therapy

- Results begin to confirm the microbiome effects seen in Phase 1 healthy volunteers, indicating that microbiome effects may be predictive of beneficial patient outcomes including low rates of recurrence.

STATEN ISLAND, N.Y., Oct. 4, 2021 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that a scientific abstract and poster were presented on September 29th at the Infectious Disease Society of America (IDSA) IDWeek(tm) 2021 Virtual Conference entitled: "An Open-label Phase 2a study of Ibezapolstat, a Unique Gram-positive Selective Spectrum (GPSS(tm)) Antibiotic, for Patients with Clostridioides difficile Infection." These results were presented by Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiome aspects of the clinical trial program for ibezapolstat.

The Company's upcoming Phase 2b segment of this clinical trial will also evaluate pharmacokinetics (PK) and microbiome changes from baseline and continue to test for anti-recurrence microbiome properties seen in the Phase 1 trial, including the treatment-related changes in alpha diversity and bacterial abundance. The Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment as well as the observed overgrowth of healthy gut microbiota Actinobacteria and Firmicute phyla species during and after therapy. According to Dr. Garey, "The good tolerability, promising efficacy outcomes, minimal systemic exposure, and differential microbiome effects relative to vancomycin all support the continued clinical development of ibezapolstat. He added: "Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. Furthermore, ibezapolstat demonstrated decreased proteobacteria overgrowth in contrast to vancomycin."

Robert J. DeLuccia, Executive Chairman of Acurx, stated, "We are particularly excited by these results in CDI patients which are consistent with the favorable microbiome profile when compared with vancomycin in our earlier Phase 1 healthy volunteer trial. He further stated that "We look forward to beginning enrollment in our Phase 2b trial which will compare ibezapolstat to the standard of care, vancomycin, and is expected to begin enrollment this quarter."

Dr. Garey's E-Poster Scientific Exhibit can be viewed on the company's website www.acurxpharma.com, Tab: News Media, Presentations.